Golden Opportunity for Chiropractic : Fraud and Scandal Surrounding Central Nerve System Depressants

March 13, 2009 · Filed Under Main Content · 1 Comment 

shakeTuesday’s bombshell that a key researcher involved in the Neurontin and Lyrica research faked the study results and invented patients takes the fraud and deception surrounding these drugs to a whole new level. This comes as new reports continue to surface about alleged fake medical articles Pfizer planted to sell the earlier half of this dynamic duo of central nerve system depressants, Neurontin, for unapproved uses from 1995 to 2002.

But it doesn’t seem to be slowing down the marketing machine promoting these new chemicals, which work by shutting down nerve system function. Remember, the pharmaceutical answer to nerve interference is to chemically shut down the messenger network.

Pfizer gave nonprofits $2.1 million in grants in 2008 for medical courses about the pain-and-fatigue ailment fibromyalgia for which its Neurontin follow-up pill, Lyrica, just happens to be approved.

Lyrica (pregablin), affectionately called Son of Neurontin at Pfizer, was discovered by Northwestern University chemist Richard Silverman in 1989, earning the university a cool $700 million when it sold royalties in late 2007.

Pfizer is funding the $100 million Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics, under construction now, which will employ 245 faculty, staff and research assistants.

Like Neurontin (gabapentin), Lyrica (Pregablin) is an anti-epilepsy drug (AED) that modulates calcium channels to dampen the excitability of nerve endings. And, like Neurontin which made $3 billion a year from unapproved uses like pain, bipolar disorder, attention deficit disorder and restless legs syndrome, Pfizer has high hopes for Lyrica’s “crossover appeal.”

Lyrica was approved in 2006 for partial onset seizures and nerve pain associated with diabetes and shingles. But the FDA’s approval of Lyrica as the first drug for fibromyalgia in 2007 is what kicked sales up 37 percent in the third quarter to $465 million.

Fibromyalgia, with no clear cause, blood test, definition or cure “is almost a textbook definition of an unmet medical need,” enthused Pfizer VP Ian Read in a conference call to analysts when the drug first launched.

Datamonitor predicts the fibromyalgia market can be “grown” from $400 million to $2 billion thanks to all the people who do not know they have it yet.

And even before the name Lyrica appeared, Pfizer’s initial “unbranded” campaign of public service announcements (PSAs) in conjunction with the National Fibromyalgia Association that featured people describing their symptoms and hawking the web site www.fibrohope.org laid the groundwork for massive sales of Lyrica, once FDA approved.

(Think Merck’s “unbranded” HPV awareness campaign that preceded the vaccine Gardasil’s FDA approval)

Despite a temporary Lyrica scare in 2001 when Pfizer had to freeze patient trials because mice developed cancerous tumors–luckily for Pfizer, rats did not-Lyrica was well received by the “medical community”.

Except the “medical community” was made up of Pfizer paid mouthpieces.

“Well tolerated,” said Pfizer paid doctors in Arthritis and Rheumatism in 2005.

“Proven efficacy” and “No new adverse events,” said Pfizer paid doctors in Drugs of Today in 2005 and 2007.

And, “Durability of effect for relieving FM pain,” said Pfizer paid doctors in the journal Pain in 2008.

Actual Lyrica users were less overenthusiastic, reporting memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and even two deaths reported on the website askapatient.com. The FDA added suicide warnings to Lyrica and all AEDs in 2008.

Pfizer and other drug manufactures will be ratcheting up the “patient education” and awareness campaigns for fibromyalgia. But in doing so, they have been forced to admit that a primary causal factor in these symptoms is nerve interference. Otherwise, there would be no justification for prescribing nerve system depressants as a treatment for said symptoms.

As chiropractors, it is our duty to inform the public that there is an alternative to treating nerve interference with a drug that causes all of the above side effects including an increased likelihood of suicide.

As a chiropractor, you know that chemically suppressing nerve system function cannot possibly be wise. The drug does not selectively shut down only nerves transmitting pain signals. It depresses all nerve function to all tissue cells: brain, heart, lungs, kidneys, etc. These chemicals have the exact opposite objective as the chiropractic adjustment. Just imagine what the long term effects of these drugs will be. They effectively create a chemical subluxation of the entire nerve system.

The fact that the drug was possibly approved based on faked research and promoted via fake articles in medical journals presents a unique opportunity for the chiropractic community. We must take full advantage of the awareness campaigns for the “unmet medical need” Pfizer VP Ian Read is so excited about. But instead of a suicide inducing chemical, we offer life enhancing subluxation correction with the only side effect: clinically proven increased quality of life.

Of course, this can only be accomplished with a unified effort, chiropractors working together and pooling their resources to get the message out there. This is exactly the type of opportunity Chiropractic America’s YourSpine.com initiative was designed to capitalize on. Do your part by becoming a member today!

Key Researcher Advocating Lyrica and Neurontin for Pain Allegedly Faked Studies, Invented Patients

March 11, 2009 · Filed Under Main Content · 1 Comment 

quack1A widely known Massachusetts anesthesiologist whose research has widely influenced how doctors treat surgery patients for pain has been accused of fabricating results in at least 21 published studies and, in some cases, even inventing patients.

Physicians and journal editors said the allegations, if proven, could constitute one of the largest and longest-running cases ever of medical research fraud.

Dr. Scott S. Reuben, who works at Baystate Medical Center in Springfield, has published dozens of articles on “multimodal analgesia,” an important and emerging area of anesthesiology involving use of more than one type of drug to relieve post-surgical pain and foster faster recovery.

Last May, during a routine review of research summaries that were to be presented at the hospital’s research week, physicians discovered that the research Reuben intended to present had not been approved by an internal hospital review board that oversees research on patients, Dr. Hal Jenson, Baystate’s chief academic officer, said yesterday.

That discovery led to a full-scale investigation by the hospital, which was completed in January. The investigation uncovered 21 published papers over 13 years in which Reuben made up some or all of the data, Jenson said.

Jenson said that in many cases “there was no clinical trial because there were no patients.”

The hospital notified several medical journals about the results of its investigation, and the journals are in the process of retracting Reuben’s papers, said Jenson.

“This would be the largest research fraud in anesthesia,” said Dr. Steven Shafer, editor of the journal Anesthesia and Analgesia. “Doctors have been using [his] findings very widely. His findings had a huge impact on the field. The act of fabricating data is so difficult for me to comprehend. It’s beyond my ability to imagine.”

Dr. Greg Koski, an anesthesiologist at Massachusetts General Hospital and former director of the federal Office for Human Research Protections, said the case is unusual, not because of the number of journal articles involved, but because of the number of years the deception is alleged to have gone on.

“That’s what makes this so remarkable,” he said. “. . It seems to have gone on for so long without being detected by the peer review process. It’s hard to fake something for that long. Pain research is not an obscure area; people look at it all the time.”

Celebex, Lyrica and Neurontin Research Part of the Fraud

In some instances, the studies in question involved data about drugs made by pharmaceutical giant Pfizer Inc., including Celebrex, Lyrica, and Neurontin. The company gave Reuben five research grants between 2002 and 2007, and he was a member of Pfizer’s speakers bureau, in which physicians give talks about Pfizer drugs to colleagues.

In response to the news of this fraud, Pfizer spokeswoman Sally Beatty said the clinical trials that led the US Food and Drug Administration to approve Celebrex and Lyrica for pain did not include Reuben’s research. Celebrex was approved to treat acute pain, including that following surgery, in 2001. Lyrica is not approved for the treatment of acute pain, but doctors can use the drug for that purpose “off-label.” The company’s statement did not address Neurontin.

*It should be noted in the above quote from Pfizer spokeswoman Beatty that it is illegal for a drug company to suggest off-label use of the drug for pain as Beatty does above.

“It is very disappointing to learn about Dr. Scott Reuben’s alleged actions,” Pfizer said in a statement, adding that the company was “not involved in the conduct of any of these independent studies or in the interpretation or publication of the study results.”

The fraud allegations were first reported this week by Anesthesiology News.

Although Reuben often co-wrote papers with other researchers, Jenson said Baystate found that the other researchers did not know about or participate in the alleged fabrications.

In a Feb. 20 letter to readers posted online, Shafer said his journal will publish formal retractions of Reuben’s studies published in Anesthesia and Analgesia in May.

Anesthesiologists agreed there will be an impact on the field, but disagreed over how significant it would be.

Dr. James Rathmell, chief of the Massachusetts General Hospital pain clinic, said the effect is unknown.

“Reuben’s idea of adding Lyrica and Neurontin to the mix.”

“He had some important findings that were very encouraging to all of us,” he said. But, he said, many other researchers have published positive results for Celebrex and other Cox-2 inhibitors for treatment of surgical pain. More in question, he said, is Reuben’s idea of adding Lyrica and Neurontin to the mix. “He’s done the few studies in that area,” Rathmell said.

Shafer, however, said researchers and physicians are going to reexamine the literature and may have to repeat clinical trials. “We have to be open to the possibility there was patient injury,” he said, despite the relative safety of the drugs in question. “Nothing is without risk.”